151. Primary Care Providers are Magicians, SGLT2 Inhibitors, and Peanut Allergy

https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2771095
SO HOW DO YOU LOSE WEIGHT!!

FASTING DOESN’T WORK or so says this study titled- Effects of Time-Restricted Eating on Weight Loss and Other Metabolic Parameters in Women and Men With Overweight and ObesityThe TREAT Randomized Clinical Trial
100 overweight or obese adults were randomized to regular eating or to a restricted eating pattern where you could not eat between 8pm and 12 noon and the result were no statistical difference between the group that at three meals a day and the group that could only eat between 12 and 8.

Here is the problem-
People could eat anything
You basically are only restricting breakfast. What grown adult eats a ton for breakfast. I mean sure there aer some but the majority of people I know maybe have a hard boiled egg or a piece of toast but never a huge meal. How many EXTRA calories are these people really getting??
I think a better way to do this trial would have been 12 hours of fast but make the hours 5am to 5pm or some random time frame in which you limit the person to not eating for TWO meals, breakfast and lunch. DON’T say hey you can only eat between 12 and 8 because that means that they can eat lunch and dinner.
This is a poorly done study and I wouldn’t be so fast to throw out time restriction eating I think there is still plenty of data saying it can and does work but one should be aware this study is out there.




A good magic trick makes you think one thing when something else is going on and I often wonder how often that happens in medicine, like I seen in this article

https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2771506?guestAccessKey=5cac67ed-13a3-4b78-b201-61c95f31bec9&utm_source=silverchair&utm_medium=email&utm_campaign=article_alert-jamainternalmedicine&utm_content=olf&utm_term=100520


Early Noninvasive Cardiac Testing After Emergency Department Evaluation for Suspected Acute Coronary Syndrome

Which was a retrospective study using data from kaiser permanente looking to find if noninvasive cardiac testing (NIT) after an emergency department (ED) evaluation for acute coronary syndrome lowered the 30 day risk of death or acute myocardial infarction???
Sure a patient comes in for chest pain and the recommendations are for noninvasive cardiac testing within 72 hours but what is the evidence for this?? Do follow up stress ECG, stress echocardiogram, stress myocardial perfusion, or a coronary CT angiogram actually make a difference???

The result they give is like magic—they found noninvasive testing lead to improvements at 30days with The number needed to treat was 250 to avoid 1 death or MI, 500 to avoid 1 death, 333 to avoid 1 MI, and 200 to avoid 1 major adverse cardiovascular event within 30 days.

BUT was it the test that made a difference?? because this is where the magic happens.

There was no difference in the rates of revascularization procedures. So people have more test but they are not then having subsequent revascularization procedure.
LIKELY something else is going on?? Like what you ask?? A good PCP and medical optimization – those that had the noninvasive extra test had stastically higher rates of antihyperlipidemics (16.1% vs 9.7%; P 

And speaking of magic—what about a pill you can take that would take away your peanut allergy. That sounds like magic!! Or at least that is what the drug reps will want you to believe about the newest drug Palforzia also known as peanut allergen powder

This is an oral immunotherapy for those with peanut allergy
It is for kids 4 – 17 yrs old and if taken correctly about 2/3 of kids will be able to tolerate exposure to about 2 peanutes.. wait did I just say they can tolerate 2 peanuts??

Yes that because once you start palforzia you take this medication FOR LIFE and you must maintain a peanut free diet – this is a not a peanut free party where you can jump in both feet into a payday candy bar.
The drug cost about 900$ a month AND Palforzia is linked to more epinephrine use than peanut avoidance alone… this sounds great in theory—TREAT PEANUT ALLERGIES. BUT to have access to only 1-2 peanutes it seems like 900$ is a lot of money for half a bite of a peanut butter and jelly sandwhich… I likely wont presribe this drug and just continue to encourage peanut avoidance but for the select few that get a peanut anaphalaxis just but walking past the peanut butter cookies then just maybe palforzia is for you.



2020 is not great for many people but those people are not SGLT2 inhibitors an article in NEJM titled
https://www.nejm.org/doi/full/10.1056/NEJMoa2024816
“Dapagliflozin in Patients with Chronic Kidney Disease”

4000 adults with CKD, mean gfr of 43 were randomized to 10 mg of dapagliflozin or placebo daily. after follow-up of 2.4 years, the primary composite outcome was — decline of at least 50% in estimated GFR, end-stage kidney disease, or renal or cardiovascular death — occurred was less often in the dapagliflozin group 14.5% vs the placebo 9.2%. which makes a NNT of 20 to prevent renal decline and death.

The flozins seems to be people drugs, not diabetic drugs and next time on rounds speak proudly when you say

dapagliflozin can lower the risk for kidney disease progression and death in patients with chronic kidney disease (CKD) — even when they don’t have diabetes.

And then don’t speak so loud and proud when you tell your patient that for a 30 day supply it cost $500 per good RX. Which mean for a NNT of 20 people to take the medication for follow up of 28months it would cost $280,000….






https://www.fda.gov/safety/medical-product-safety-information/invokana-invokamet-invokamet-xr-canagliflozin-medwatch-safety-alert-boxed-warning-about-risk-leg-and

https://www.bmj.com/content/370/bmj.m2812

The FDA says the boxed warning about the risk for leg and foot amputations can be removed from canagliflozin's label.
Based on FDA's review of new data from three clinical trials,
warning was added to the sodium-glucose cotransporter-2 (SGLT2) inhibitor in 2017 after several studies found an increased risk for lower-limb amputation. The FDA says that recent studies have found a lower amputation risk than previous studies — especially when patients were monitored — although the risk is still elevated.
recent study in The BMJ titled Risk of amputation with canagliflozin across categories of age and cardiovascular risk in three US nationwide databases: cohort study – in which Patients newly prescribed canagliflozin were propensity score matched 1:1 with patients newly prescribed a glucagon-like peptide-1 (GLP-1) receptor agonist
the study showed
estimates that one lower-limb amputation would occur for every 556 patients treated with canagliflozin instead of a glucagon-like peptide-1 (GLP-1) agonist over 6 months.
that is, 18 more amputations per 10 000 people who received canagliflozin).

Sglt2 inhibitors prevent chf. They reverse CKD they are a magic drug, or at least work for outcomes we have rarely ever seen.

Start the drug, start low dose, the benefit seems to occur at lower doses with harm at higher doses but do foot exams!